AJDJUSTABLE SUCTION CONTROL VALVE
FDA 510(k) clearance K851406 · decided 1985-08-05
Clearance details
- K-number
- K851406
- Device name
- AJDJUSTABLE SUCTION CONTROL VALVE
- Applicant
- American Omni Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-09
- Decision date
- 1985-08-05
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- DWD
- Device class
- 2
- Regulation number
- 870.4430
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.